Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
Study NCT ID:
NCT03972150
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2019-05-31
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Find the Best Dose of BI 836880 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
An Open Label, Phase I Study of BI 836880 Monotherapy and Combination Therapy of BI 836880 and BI 754091 in Japanese Patients With Advanced Solid Tumours
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this trial is:
Part I
* To determine Maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BI 836880 monotherapy Part II
* To determine MTD and/or RP2D of the combination therapy of BI 836880 and BI 754091
The secondary objectives are:
Part I
* To document the safety and tolerability, and characterise pharmacokinetics (PK) of BI 836880 as monotherapy Part II
* To document the safety and tolerability, and characterise PK of the combination therapy of BI 836880 and BI 754091
Part I
* To determine Maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BI 836880 monotherapy Part II
* To determine MTD and/or RP2D of the combination therapy of BI 836880 and BI 754091
The secondary objectives are:
Part I
* To document the safety and tolerability, and characterise pharmacokinetics (PK) of BI 836880 as monotherapy Part II
* To document the safety and tolerability, and characterise PK of the combination therapy of BI 836880 and BI 754091
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: